510(k) · Cleared

Cleared

Tongue Klean

K973175510(k) TraditionalCleared Oct 14, 199750-day reviewClass I21 CFR 872.6855

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Oct 14, 1997 as substantially equivalent to K962941 (Deep Trading Corp., 1996) after a 50-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided: Oct 14, 1997
Review: 50 days
Class: Class I
Product code: LCN
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962941 (1996). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK962941 Oolitt Tongue Cleaner, Regular Low Ripple/Special High Ripple/Low…Deep Trading Corp. · 1996
This deviceK973175 Tongue KleanSoftek Ent. · 1997
Descendant · cites it directly · 0 of its ownK990344 Oralgiene Tongue CleanerOralgiene USA, Inc. · 1999

Most influential descendants

Showing 1 of 1 · See all

K990344Oralgiene Tongue CleanerOralgiene USA, Inc. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962941	Oolitt Tongue Cleaner, Regular Low Ripple/Special High Ripple/Low Ripple…	Deep Trading Corp.	1996	—
0 (this device)	K973175	Tongue Klean	Softek Ent.	1997	—
+1	K990344	Oralgiene Tongue Cleaner	Oralgiene USA, Inc.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K973175, 1996–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LCN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K962941	Oolitt Tongue Cleaner, Regular Low Ripple/Special High Ripple/Low Ripple Double/High &… Summary page 1 …510(k) QCT 4 197 TRADE NAME: Tongue Klean CLASSIFICATION NAME: Tongue Scraper COMMON NAME: Tongue Scraper Predicate Device: OOLITT, D.T. Corp., Premarket Notification K 962941 Device Description Softek’s Tongue Klean is a simple device which is used to scrape build up of plaque from the surface of the t…	Deep Trading Corp.	1996	—

Also cleared against K962941: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K990344	Oralgiene Tongue Cleaner	Oralgiene USA, Inc.	1999	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K990344 (Oralgiene USA, Inc., 1999) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K962941.

How does its category compare?

All LCN devices

LCN Scraper, Tongue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LCN

FDA has decided no LCN device since 2007.

Median 510(k) review, days · LCN

Too few LCN 510(k)s in any year since 2007 to give a median.

Recalls per year · LCN

No recall names LCN since 2007.

Adverse event reports per year · LCN

1in 2024

2007high 1 (2024) · low 0 (2007)2025

MAUDE reports naming product code LCN, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	1
2025	—	0
2026	—	—

What is it indicated for?

Tongue Klean is indicated for use as part of the daily oral hygiene to remove plaque from the surface of the tongue.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973175 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973175: Tongue Klean.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973175

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026